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PR Newswire

On-Device AI Healthcare Company Noul Announces 2 Clinical Performance Studies at Pan-African Malaria Conference

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  • miLab showed almost equivalent to WHO-certified first-degree microscopy experts: Sensitivity of 94.4%, Specificity of 98.1%
  • African authority on malaria diagnosis said “miLab is a potential game changer in accelerating access to parasitological confirmation”

YONGIN, South Korea, April 25, 2024 /PRNewswire/ — Noul Co., Ltd., (376930.KR), an On-Device AI healthcare company, announced that the results of a clinical performance study of its malaria diagnostic solution showed a sensitivity of 94.4%, and a specificity of 98.1%, which is almost equivalent to WHO-certified first-degree microscopy experts.

[Poster] Analytical Performance Experimentation assessment of the miLab™ MAL Malaria system for the detection of Plasmodium falciparum in clinical samples in Lagos, Nigeria
[Poster] Analytical Performance Experimentation assessment of the miLab™ MAL Malaria system for the detection of Plasmodium falciparum in clinical samples in Lagos, Nigeria

Noul participated in the Multilateral Initiative on Malaria Pan-African Malaria Conference (MIM PAMC) held in Kigali, Rwanda from April 21 to 27, and reveals two of the latest clinical performance studies conducted with its malaria diagnostic solution ‘miLab™ MAL’, in three major African countries, Nigeria, Ethiopia, and Ghana, through a poster presentation.

The study was conducted to verify the effectiveness of miLab™ MAL’s each use-case. And as a result, miLab™ MAL reached a sensitivity of 94.4% and a specificity of 98.1% for P. falciparum diagnosis, and a sensitivity of 97% and a specificity of 97.6% for P. vivax diagnosis. Based on these clinical achievements, Noul plans to actively promote cooperation with global research institutes and the health departments of each country. The achievements through collaborative research are expected to be published as papers within the year. 

Dr. Wellington A.Oyibo, a Chair of the Malaria Operational Research Expert Group of the National Malaria Program (MOREG) and a Professor of Lagos University who directed the research in Nigeria, said “miLab™ MAL is a potential game changer in accelerating access to parasitological confirmation and an asset to malaria control programs. Effective deployment of miLab™ MAL could provide critical data for accurately assessing malaria infection rates and severity, optimizing resource allocation and response strategies. This information is vital for health policymakers to design more effective prevention and case management programs.”

Dr. Taehwan Kim, Managing Director of noul GmbH said, “Africa is a huge single market, accounting for about 20% of the world’s population, and a place with 95.4% of the malaria burden occurring worldwide. By disclosing the excellent clinical performance of our malaria product at the conference involving the entire continent of Africa, we intend to establish specific cooperation relationships with key stakeholders in key markets such as global pharmaceutical companies and international organizations and actively seek new business opportunities.”

Meanwhile, the Multilateral Initiative on Malaria (MIM), established in 1997, is a global alliance of citizens, institutions, funding partners, and members united by the goal of enhancing scientific research capabilities in Africa and controlling and eradicating malaria. The Pan-African Malaria Conference (PAMC) is held every four years, marking its eighth anniversary this year. Major sponsors include the Bill & Melinda Gates Foundation and the Medicine for Malaria Venture (MMV).

About Noul

On-Device Healthcare Company, Noul is recognized for its innovative technology as the first AI-based diagnostic platform company in the blood and cancer sector, with miLab™ platform introduced as “the most advanced digital microscope and fully integrated bench-top platform” in UNITAID’s report in 2022.

Website https://noul.kr/en/

PR Newswire

Lunit’s AI-Powered Lung Cancer Screening Solution Significantly Affects Radiologists’ Diagnostic Determination – Published in Radiology

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– Recent study conducted by Seoul National University Hospital provides strong evidence that high-accuracy AI model improves radiologists’ chest X-ray analysis performance

SEOUL, South Korea, July 3, 2023 /PRNewswire/ — Findings from a recent study demonstrate that medical AI solutions with only high diagnostic accuracy can significantly improve the reading performance of radiologists.

Lunit's chest X-ray AI analysis solution 'Lunit INSIGHT CXR'
Lunit’s chest X-ray AI analysis solution ‘Lunit INSIGHT CXR’

Lunit (KRX:328130.KQ), a global provider of AI-powered cancer diagnostics solutions, today announced the publication of a study exploring the impact of medical AI solutions’ accuracy on radiologists’ diagnostic determination. The study, conducted by Seoul National University Hospital from December 2015 to February 2021, was recently published in ‘Radiology,’ a renowned peer-reviewed journal in medical imaging.

The study involved a cohort of 30 doctors, including 20 board-certified radiologists with 5 to 18 years of expertise and 10 radiology residents with 2 to 3 years of training. A total of 120 retrospectively collected chest radiographs were assessed, with 60 obtained from patients with lung cancer and the remaining 60 showing no abnormalities.

During the first session, the 30 readers were divided into two groups and analyzed 120 chest X-rays each without the assistance of AI. In the subsequent session, each group reinterpreted the images with the aid of either a high-accuracy or low-accuracy AI model.

The high-accuracy AI model utilized in the study was Lunit INSIGHT CXR, Lunit’s commercially available AI solution for chest X-ray analysis. In contrast, the low-accuracy model was trained using only 10% of the data available to Lunit INSIGHT CXR. The AUROC (area under the receiver operating characteristic curve), a commonly used metric for diagnostic accuracy, of Lunit INSIGHT CXR was 0.88, while the low-accuracy AI model only reached 0.77.

The study revealed that using the higher-accuracy AI model, Lunit INSIGHT CXR, significantly improved radiologists’ performance. The AUROC was remarkably advanced from 0.77 to 0.82 when assisted by the high-accuracy AI model.

Conversely, the radiologists from the other group did not experience any performance improvement when utilizing the low-accuracy AI model, as the AUROC remained at 0.75. Moreover, the group that employed the high-accuracy AI model demonstrated a higher susceptibility to AI suggestions. The radiologists accepted 67% of AI recommendations that contradicted the initial reading results, compared to 59% acceptance of the group that utilized the low-accuracy AI model.

Moreover, the study findings highlighted that factors such as radiologists’ individual expertise, experience with AI, or attitudes toward AI had negligible impact on their reading performance in the second session. Instead, the accuracy of the AI model and the radiologists’ initial diagnostic accuracy emerged as the primary determinant shaping the final diagnostic determination.

These findings underscore the significance of the AI model’s performance when radiologists use AI as a second reader. Furthermore, the study demonstrates how such AI assistance can increase radiologists’ susceptibility to AI suggestions, ultimately contributing to more accurate diagnoses.

“The study backs that irrespective of radiologists’ individual characteristics, the utilization of high-performance AI significantly enhances diagnostic accuracy and fosters a greater acceptance of AI within medical practices,” said Brandon Suh, CEO of Lunit. “At Lunit, we are committed to developing AI-powered solutions that not only improve patient outcomes but also augment the expertise of healthcare professionals. This publication is a testament to our dedication to advancing the field of cancer diagnostics through cutting-edge technology.”

Radiology, owned and published by the Radiological Society of North America (RSNA), is a prestigious publication with a distinguished Impact Factor of 29.146, making it the number one ranked journal in the field of medical imaging.

About Lunit

Lunit is a deep learning-based medical AI company on a mission to conquer cancer, one of the leading causes of death worldwide. Our focus is on developing AI solutions for precision diagnostics and therapeutics, ensuring the right diagnosis, and treatment, at the right cost for each patient. Lunit focuses on developing advanced medical image analytics and AI-based biomarkers via cutting-edge technology.

Founded in 2013, Lunit has been acknowledged around the world for its advanced, state-of-the-art technology and its application in medical images. Its technology has been recognized at international AI competitions surpassing giants like Google, IBM, and Microsoft. As a medical AI company grounded on clinical evidence, the company’s findings are presented in major peer-reviewed journals such as the Journal of Clinical Oncology and JAMA Network Open, and global conferences including ASCO and AACR.

After receiving FDA clearance and the CE Mark, our flagship products, Lunit INSIGHT CXR and Lunit INSIGHT MMG, are clinically used in approximately 2,000 hospitals and medical institutions across 40+ countries. Lunit is headquartered in Seoul, South Korea with offices and representatives worldwide.

PR Newswire

Vela Diagnostics Develops PCR-based Test for Detecting Monkeypox Virus

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SINGAPORE, July 26, 2022 /PRNewswire/ —  Vela Diagnostics announced that it has developed a PCR test kit to detect the monkeypox virus (MPXV), for research use only (RUO).

The ViroKey® MPXV PCR Test allows for the prompt, in vitro detection of MPXV DNA from human skin lesion specimens. It is compatible with common real-time PCR cyclers, such as the Rotor-Gene Q and Applied Biosystems 7500 series platforms. In silico testing shows that the assay is specific for MPXV and has no cross-reactivity with other orthopoxviruses.

“We worked closely with our customers to develop a test that is specifically designed to meet their requirements, making sure that they have a monkeypox-specific assay, with maximum flexibility to choose between manual and automated workflows depending on the number of samples they receive,” said Dr Charlie Lee, Head of Research and Development at Vela Diagnostics.

The monkeypox outbreak has been declared a global health emergency by the World Health Organization (WHO), with over 16,000 cases worldwide. The mode of transmission is thought to be close, sustained physical contact with other people who have monkeypox. The WHO has requested for all countries to provide testing for any individuals that meet the suspected case definition, and to immediately notify it in the case of positive laboratory results.

“Throughout the COVID-19 pandemic, we have worked closely with various testing labs across the globe. We responded quickly to the monkeypox epidemic by allowing research partners and laboratories to offer timely and accurate monkeypox testing,” said Sam Dajani, CEO of Vela Diagnostics and Chairman of the Board. “We have already released the first few batches of kits, and they are being evaluated by our customers globally. We are committed to increasing testing capacity of monkeypox in hopes of containing the spread of the virus.”

For more information; including the IFU, please contact us.

About Vela Diagnostics

Vela Diagnostics is a leading provider for integrated IVD system solutions, from sample to result. VELA’s test solutions utilize the automated SentosaTM platform, providing the unique ability to leverage one system for NGS and PCR testing in infectious disease and oncology.

All Sentosa products listed above are by Vela Diagnostics. For more information, visit www.veladx.com. All other product names, trademarks and logos are the property of their respective owners.

Cision View original content:https://www.prnewswire.com/news-releases/vela-diagnostics-develops-pcr-based-test-for-detecting-monkeypox-virus-301593161.html

PR Newswire

IFN Neurologic and MetaCell Partner to Launch the IFN Neurologic Affiliate Program

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CAMBRIDGE, Mass., and PERTH, Australia, June 28, 2022 /PRNewswire/ —

Summary

The Institute of Functional Neuroscience, a world leading treatment and rehabilitation centre utilising the latest technologies in neuroplasticity research, and MetaCell, an innovative life science software company specialised in cutting-edge research software for major pharma, biotech, and academic institutions, have partnered to launch IFN Neurologic. This application will help clinicians to better serve patients with neurological disorders and provide treatments in the functional neuroscience domain. The application has been piloted with a limited number of clinics in 2021/2022, and now is made available to clinics and patients worldwide.

IFN Neurologic is an innovative application to help clinicians better serve patients with neurological disorders and provide treatments in the functional neuroscience domain
IFN Neurologic is an innovative application to help clinicians better serve patients with neurological disorders and provide treatments in the functional neuroscience domain

Affiliate Program 

Affiliate clinics will use for the first time IFN Neurologic to perform restorative neuroplasticity interventions on their patients at their own clinic. The affiliate program includes a comprehensive education program accredited by IFN (Institute of Functional Neuroscience) and AICN (Australian Institute of Clinical Neuroscience), all the necessary hardware/software, and access to the IFN Neurologic platform.

The team

Dr. Randy Beck, PhD, Director of the IFN, said: “We’re excited to be launching this new application in partnership with MetaCell. With this new software that requires no installation and can be reached from any web browser in the world, we now have the ability to rapidly scale up our diagnostic processes and reach more patients around the world at the click of a button.”

Giovanni Idili, COO of MetaCell, added: “We are very proud to work with Dr. Beck and provide IFN with a solution that ultimately allows the organisation to help a much greater number of patients at the same outstanding level of service, and we look forward to partnering with many more clinical innovators using our unique approach to custom software development in concert with our clinical neuroscience platforms.”

About IFN

The Institute of Functional Neuroscience (IFN) utilises the latest in neuroplasticity and neuroscience research to develop treatment approaches aimed at improving brain and nervous system performance of patients with a wide range of conditions including migraines, seizure disorders, strokes, attention deficit disorders, obsessive compulsive disorder, developmental coordination delay, vertigo, depression, learning and developmental disorders, concussion syndromes and autism.

About MetaCell

MetaCell is a life science-focused software company composed of scientists and software engineers, with deep domain expertise in computational neuroscience, molecular biology, data science, and enterprise-grade online software development. Their solutions have been trusted for over a decade by some of the world’s largest pharmaceutical companies and leading research institutions in the USA, UK, Australia, Canada, and Europe, including Biogen, Pfizer, Eisai, Salk, UCL, Mount Sinai, UCSD, Yale, Princeton, and many more.

Contact details

IFN Neurologic: https://ifnneurologic.com/ | +61 (08) 6254 2282 | affiliateprogram@ifnneurologic.com
IFN: https://ifn.net.au | +61 (08) 6254 2282 | info@ifn.net.au 
MetaCell: https://metacell.us/ | US +1 617-286-4832 | UK +44 1865 648684 | info@metacell.us

PR Newswire

Under the Patronage of His Highness Sheikh Theyab bin Mohamed bin Zayed Al Nahyan, Abu Dhabi Early Childhood Authority’s WED Movement Engages Global Experts to Drive Innovation, Excellence in Early Childhood Development

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ABU DHABI, UAE, Aug. 17, 2021 — Abu Dhabi’s World Early Childhood Development Movement (WED Movement) has launched a new initiative bringing together global experts to develop innovative and actionable solutions advancing Abu Dhabi’s vision to be a leader in Early Childhood Development.

Cecilia Vaca Jones, Executive Director of the Bernard van Leer Foundation, and Chair of the BWG
Cecilia Vaca Jones, Executive Director of the Bernard van Leer Foundation, and Chair of the BWG

WED Movement was established earlier this year under the patronage of His Highness Sheikh Theyab bin Mohamed bin Zayed Al Nahyan, Chairman of Abu Dhabi Crown Prince Court and Chairman of the Abu Dhabi Early Childhood Authority (ECA). Under ECA, WED Movement is harnessing the expertise of a multidisciplinary group of 21 early child development experts representing a mix of academics, healthcare practitioners, policy influencers, children’s media and entertainment specialists, global business leaders and technical consultants. The experts come from several world-renowned institutions such as UNICEF, World Bank, UNESCO and Harvard University, as well as a number of global companies in technology and entertainment.

Participants are working in one of three Breakthrough Working Groups (BWGs), each focused on a unique and important aspect of how children’s mental, physical and cognitive abilities develop in the earliest years of life, from pregnancy to 8 years old. The BWGs are focused on Emotional Wellbeing & Social Interaction, Tech Humanity for Children, and 21st Century Lifestyle.

To date the BWGs have held nearly 100 strategic planning sessions and met with more than 65 parents, children, teachers and ECD experts in the UAE as part of their work towards creation of a series of innovative solutions that promote the holistic healthy development of Abu Dhabi’s young children. These solutions will also help parents and caregivers address some of the most common challenges faced during the earliest years of child growth and development. Outcomes from these sessions include policy recommendations, creation of specific programs and initiatives, development of products, as well as guidelines to address the identified issues.

Team members are coordinating directly with a range of government and social service entities, including Abu Dhabi Department of Community Development, Abu Dhabi Department of Health, Abu Dhabi Department of Education and Knowledge and Zayed Higher Organization for People of Determination. They also have commissioned independent research on such issues as child screen time, technology use in the home, play time and social interaction. 

WED Movement and the work of the BWGs reflects Abu Dhabi’s commitment to deliver on its vision to invest in breakthrough innovation in early childhood development with the goal of nurturing a generation of conscious youth who have the knowledge and skills to adapt to rapidly changing societal challenges and contribute to building a better society. The BWGs aim to play a significant role driving the level of innovation needed while helping establish Abu Dhabi as a global role model for and contributor to excellence in early childhood development. 

The BWGs work under the guidance of Cecilia Vaca Jones, Executive Director of the Bernard van Leer Foundation, and Chair of the BWG, alongside His Excellency Omar Saif Ghobash, Assistant Minister for Cultural Affairs at the UAE Ministry of Foreign Affairs and International Cooperation (MoFAIC), and Co-Chair of the BWG.

Chair Cecilia Vaca-Jones said: "This Breakthrough Working Group approach enables us to tap into a global collection of world-class early childhood development experts with a single mission and focus: helping Abu Dhabi create the best possible environment to give our children the opportunity in life each and every one deserves. And these new programs, policies and initiatives that we pioneer here at home can become models for early childhood development that are adopted in nations around the world."

The BWGs are currently researching and assessing issues as well as exploring potential solutions related to the following themes:

  • Emotional Wellbeing and Social Interaction: Creating an ecosystem that can help reduce emotional strains on children, parents and caregivers while promoting continuous interactions with children that help them establish important social interaction skills at early ages.
  • Tech Humanity for Children: Looking at how to ensure that children are ready for the rapidly growing level of technology in their lives and are well aware of and protected from risks in order to best reap the many benefits these new technologies offer.
  • 21st Century Lifestyle: Fostering an Abu Dhabi-wide environment that promotes a better lifestyle at home, in school and across the community and facilitates positive physical and mental health of children.

Co-Chair H.E. Omar Saif Ghobash said: "These themes represent both challenges and opportunities for fostering early childhood development not only in Abu Dhabi but across the UAE and worldwide. Through this team of experts and the BWG approach, we will look to generate recommended programs, policies and initiatives that can have a positive impact across the early childhood development ecosystem on behalf of our children, including parents and caregivers, academia, government policymakers, social support groups and the private sector."

Dr. Nikki Martyn, Program Head of Early Childhood Studies at the University of Guelph-Humber and a member of the one of the BWGs said: "Being a part of WED Movement is a truly unique opportunity to take the learnings and experiences of early childhood development experts from around the world and develop initiatives and recommendations that can quickly be put in place to directly benefit the children of Abu Dhabi. Over the longer term, we hope to see the outcomes of WED Movement work benefitting children around the world."

 

Omar Saif Ghobash, Assistant Minister for Cultural Affairs at the UAE Ministry of Foreign Affairs and International Cooperation, and Co-Chair of the BWG
Omar Saif Ghobash, Assistant Minister for Cultural Affairs at the UAE Ministry of Foreign Affairs and International Cooperation, and Co-Chair of the BWG

 

PR Newswire

Medidata Becomes First Company to Offer End-to-End, Unified, Secure Platform for Decentralization of Clinical Trials (DCT)

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  • The first company in the world to unify direct patient data capture technology with study oversight and monitoring, Medidata redefines end-to-end decentralization for sponsors and CROs
  • The unique Medidata Trial Dial™ concept provides the industry’s highest level of customization for clinical trial decentralization – enabling fully decentralized or hybrid studies

SINGAPORE, June 16, 2021 — Medidata, a Dassault Systèmes company, today announced the launch of the Medidata Decentralized Clinical Trials (DCT) Program, the most comprehensive set of unified, secure technologies that enable full decentralization across the clinical trial continuum. For the first time ever, drug, vaccine, and medical device developers (sponsors) and contract research organizations (CROs) can take advantage of the only platform offering on the market which combines:

  • Technology and workflows to virtualize patient participation
  • Tools that facilitate sponsor oversight of patient safety and data quality
  • Direct-to-patient services, including facilitation of delivery of study drugs to the home

The Medidata DCT Program captures participant data remotely from anywhere, at any time. It aggregates and transforms that data, monitors the data to identify quality issues to mitigate risk and ensure patient safety, and runs powerful analytics to draw new insights leading to better outcomes for patients, researchers, sites, sponsors, and CROs.

"The life science industry has seen accelerating interest and adoption of decentralized trial technology in the wake of the COVID-19 pandemic," said Anthony Costello, president, patient cloud at Medidata. "Sponsors and CROs are increasingly turning to decentralized trial models in an effort to bring increased efficiency, security, and accessibility to the clinical research process."

Through a range of capabilities on a common platform that can be individually turned "on" or "off" in various combinations using the Trial Dial™ concept, the Medidata DCT Program provides the highest level of customization of decentralizing solutions based on study protocol design. This allows study sponsors to adjust and choose everything from traditional onsite trials, to fully decentralized models, and every hybrid trial design in between.

The Medidata DCT Program revolutionizes the paradigm of sponsor study oversight by supporting sponsors and CROs to easily adopt risk-based approaches to study execution, rather than historically reactionary and inefficient on-site practices. Embedded capabilities for risk identification, monitoring, and mitigation allow for truly digital oversight, where physical and virtual interaction with sites can be optimized while maintaining patient safety and data quality. The Medidata DCT Program also allows for powerful workflows driven from patient-centric data, such as shipping investigational product directly to the patient and automated dosage adjustments.

"We are very proud to say that, as a trusted partner to the life science sector for more than 20 years, Medidata is now the only company providing a full suite of virtual capabilities to enable complete trial decentralization, encompassing both patient and site interactions," added Costello. "The DCT Program marks an important evolution in Medidata’s vision for how we can better serve patients and customers, by accelerating research and bringing novel therapies to market in record time."

To date, Medidata has applied its decentralizing technologies across more than 44,000 clinical sites around the world in multiple languages involving more than 600,000 patients with a wide array of illnesses. Nearly 350 sponsors and CROs have trusted Medidata to handle the increasing speed and volume of electronically sourced patient data generated by modern trials. The single platform minimizes the opportunity for data discrepancies and transfer lags, which can lead to security concerns and increased risk of trial disruption.

According to Gartner, a leading research and advisory company, "Life science CIOs advancing healthcare and life science digital optimization and modernization should… establish a technology strategy by prioritizing digital trial solutions that combine wearables, mobile apps, IoT and advanced data analytics. This will enable a truly patient-centric and decentralized approach to clinical research."[1]

The COVID-19 crisis emphasized the pivotal role of technology in accelerating safe clinical trial development. In fact, Medidata technology helped to bring a COVID-19 vaccine through the full clinical trial life cycle in under a year. For this effort, the vaccine developer used a suite of Medidata technologies, including Rave EDC (electronic data capture); eCOA (electronic clinical outcomes assessment), and Detect (centralized statistical monitoring)—these tools allowed study teams to course-correct before trial quality and timing were affected by potential risks.

Regulatory agencies around the world have begun embracing remote technology solutions, especially remote monitoring, electronic informed consent (eConsent), telemedicine, and direct shipment of investigational products to patients. Specifically, the United States Food & Drug Administration (FDA) is expected to issue a draft guidance regarding decentralized clinical trials this year, with special emphasis on endpoint analysis, data quality and control, and the appropriate use of eConsent. As a pioneer in decentralizing the clinical trial process, Medidata is primed to support the industry in the adoption and best use of these innovative new technologies.

Medidata is a wholly owned subsidiary of Dassault Systèmes, which with its 3DEXPERIENCE platform is positioned to lead the digital transformation of life sciences in the age of personalized medicine with the first end-to-end scientific and business platform, from research to commercialization.

[1]Gartner, Life Science CIOs: Map Your Pathway to Digital Trials, Jeff Smith, 18 August, 2020.

About Medidata

Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 1,700+ customers and partners access the world’s most-used platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systèmes company (Euronext Paris: #13065, DSY.PA), is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at www.medidata.com and follow us @Medidata.

Medidata is a registered trademark of Medidata Solutions, Inc., a wholly owned subsidiary of Dassault Systèmes.

About Dassault Systèmes

Dassault Systèmes, the 3DEXPERIENCE Company, is a catalyst for human progress. We provide business and people with collaborative 3D virtual environments to imagine sustainable innovations. By creating virtual twin experiences of the real world with our 3DEXPERIENCE platform and applications, our customers push the boundaries of innovation, learning and production. Dassault Systèmes brings value to more than 290,000 customers of all sizes, in all industries, in more than 140 countries. For more information, visit www.3ds.com.

3DEXPERIENCE, the Compass icon, the 3DS logo, CATIA, BIOVIA, GEOVIA, SOLIDWORKS, 3DVIA, ENOVIA, NETVIBES, MEDIDATA, CENTRIC PLM, 3DEXCITE, SIMULIA, DELMIA, and IFWE are commercial trademarks or registered trademarks of Dassault Systèmes, a French "société européenne" (Versailles Commercial Register # B 322 306 440), or its subsidiaries in the United States and/or other countries.

Related Links :

http://www.medidata.com

PR Newswire

Integrating Fitbit Wearable Devices into Diabetes Care Leads to Significant Improvements in Blood Glucose and HbA1C, Finds Health2Sync Clinical Study in Taiwan

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  • Wearing Fitbit devices with Health2Sync glucose control app clinically proven to help both users and healthcare providers to control and better manage the symptoms of Type 2 diabetes
  • Results from the study in Taiwan revealed an improvement in patients’ health conditions, with participants recording higher levels of physical activity, reduced HbA1C, fasting blood glucose and LDL-C, and higher blood glucose measurement frequency
  • The Health2Sync Patient Management Platform allows healthcare providers to seamlessly monitor patients’ information and provide remote consultative advice where necessary

SINGAPORE, Nov. 13, 2020 — Health2Sync, the number one diabetes management app in Taiwan and Japan, today announced the results of their clinical study in Taiwan, demonstrating that combining Fitbit wearable devices with their Health2Sync Patient Management Platform can help users control and better manage the symptoms of Type 2 diabetes mellitus (T2DM). In the study[1], conducted with four of Taiwan’s leading diabetes clinics, participants recorded significant average improvements in key indicators, such as reduced HbA1C, fasting blood glucose  and LDL-C, and higher blood glucose measurement frequency — a valuable proof of concept for using Fitbit wearables with diabetes care protocols and solutions.     

Voluntarily connecting their Fitbit Inspire HR with the Health2Sync App enabled study participants to let their doctors seamlessly monitor their information on the Health2Sync Patient Management Platform and provide remote consultative advice where necessary.
Voluntarily connecting their Fitbit Inspire HR with the Health2Sync App enabled study participants to let their doctors seamlessly monitor their information on the Health2Sync Patient Management Platform and provide remote consultative advice where necessary.

The study found:

  • Average glycated haemoglobin (HbA1C) decreased 0.33%, while patients who did moderate to high-intensity activity duration of at least 150 mins per week, saw their average HbA1C[2] decrease 0.66%
  • Average fasting blood glucose (BG) decreased 10.92 mg/dL
  • Average low-density lipoprotein cholesterol (LDL-C) decreased 11.55 mg/dL
  • Weight reduction of up to 2 kilograms among some patients
  • Increased frequency in moderate to high intensity activity to 7.03 times a week among some patients

Conducted over a three-month period ending in July 2020 in conjunction with the Neng-Chun Diabetes Clinic, Da-Ya Chang-An Clinic, Yier Clinic and Banqiao Da-Jun Clinic, the study, with patient consent, lets the patients’ doctors track the progress and lifestyle changes of 95 participants with T2DM. Prior to the commencement of the study, doctors at the four clinics established benchmarks for all participating patients based on blood glucose tests at the start of the trial, then on a self-monitored weekly basis throughout the study period.

Each participant was given a Fitbit Inspire HR and the participants voluntarily agreed to connect their Fitbit wearable data with the Health2Sync diabetes management app to track their progress throughout the program. Physical activity data generated from each person’s Fitbit device was integrated into the Health2Sync app, which housed other health metrics such as patients’ HbA1c, BG and cholesterol levels. This let doctors seamlessly monitor patients’ information on the Health2Sync Patient Management Platform and provide remote consultative advice where necessary.

Dr. Kuo-Liang Lu of Da-Ya Chang-An Clinic in Taiwan, said: "The results speak for themselves. We saw a reduction in some of our patients’ weight by an average of two kilograms and fasting BG levels of study participants from Da-Ya Chang-An clinic decreased 11.10 mg/dL within 3 months[3], leading to significant health improvements."

Dr. Neng-Chu Yu of Neng-Chun Diabetes Clinic said: "Type 2 diabetes, with the right lifestyle changes – medication adherence, increased activity, and better diet – can lead to major improvements in control of blood glucose levels. The integration of Fitbit data with Health2Sync let me easily view my patients’ activities and self-monitored data, enabling me to make necessary suggestions and give guidance to help patients for further improvement."

Diabetes is a chronic condition that, if not managed, can lead to health complications like blindness, kidney failure, heart attacks, stroke and lower limb amputation.[4] It remains the second highest cause in premature mortality, after cancer, among major non-communicable diseases in Taiwan[5] and its prevalence has posed economic burdens such as increased personal and healthcare spending and loss of work productivity.[6]

A holistic approach to managing T2DM requires lifestyle changes, which includes medication adherence, exercise and proper diet. The integration with Fitbit wearable devices and activity data is key to helping to promote healthier behaviours and improve participants’ health outcomes. Participants received reminders for weekly exercises via their Health2Sync App, which promoted an increased frequency in moderate to high intensity activity at 7.03 times a week. The increased levels of activity corresponded with an improvement in patients’ health conditions.

"We are thrilled to see such optimistic results in the clinical study. We believe that innovations in Fitbit wearable devices and Fitbit health solutions have a major role to play in the global effort against diabetes – whether it is in reducing the onset of diabetes, or helping patients to better manage their condition – and we look forward to further expanding on our partnership with Fitbit," said Ed Deng, CEO at Health2Sync.

"The behavioural changes exhibited by study participants reinforces our belief that Fitbit amplifies our intrinsic motivation to adopt healthier habits, which can make all the difference when dealing with a condition like Type 2 diabetes where lifestyle factors play such a big role," said Steve Morley, Vice President of International Health Solutions & General Manager of Asia Pacific at Fitbit. "Together with the seamless experience that Health2Sync provides for patients and their health providers to track key indicators, they create a powerful solution that makes it simpler and more convenient to manage conditions like Type 2 diabetes."

In September last year, Fitbit and Health2Sync collaborated to allow the integration of Fitbit’s health, sleep and fitness wearable data with the Health2Sync app (with user consent) to support Health2Sync’s 520,000 users in Japan and Taiwan to better manage their conditions, like Type 2 diabetes. The new platform gives users who have a Fitbit account access to an in-app dashboard that includes the option to agree to share their wearable data from their Fitbit devices[7], including heart rate, sleep and physical activity, alongside recent blood glucose readings from Health2Sync depicting if levels fall within, above, or below the healthy range.

[1] The study was conducted on 95 participants, ages 18- 60.

[2] The term HbA1c refers to glycated haemoglobin. Diabetics with higher levels of HbA1c face greater risk of developing diabetes-related complications.

[3] Average fasting blood glucose levels of study participants from Da-Ya Chang-An clinic decreased 11.10 mg/dL compared to the study average of 10.92 mg/dL

[4] "Diabetes" World Health Organization, 2020. https://www.who.int/news-room/fact-sheets/detail/diabetes.

[5] IC Chen., Yu NC. "A Decade of Diabetes Care in Taiwan." Diabetes research and clinical practice. U.S. National Library of Medicine, 2014. https://pubmed.ncbi.nlm.nih.gov/25550058/.

[6] Wong LC., Tsai CY., Chou HK., Tsai MT., Tsai WH., Chou.P., and Shen ST. "Healthcare costs associated with progressive diabetic retinopathy among National Health Insurance enrollees in Taiwan, 2000-2004." BMC Health Services Research, May 26, 2010. https://bmchealthservres.biomedcentral.com/articles/10.1186/1472-6963-10-136

[7] Includes Fitbit Sense, Fitbit Versa 3, Fitbit Charge 4, Fitbit Inspire 2, among others.

About Health2Sync

Health2Sync scales diabetes care by providing a digital engagement platform that is comprised of a mobile App for diabetics, cloud-based analytics, and cloud platform for healthcare providers. The smart analytics algorithms provide users with personalized education and guidance based on their biometric and behavior data captured. With the cloud platform, healthcare providers can easily take control of patients’ condition through the analyzed data.

Health2Sync is the largest diabetes management platform in Asia (excl. China) and proven to help users improve their outcome.  Health2Sync has supported partners including pharmaceuticals, private payers, and the public payor to provide diabetics with innovative services.  In 2017, 2018 and 2019 Health2Sync was selected as Top 10 Diabetes App globally by Healthline.

PR Newswire

CaDi introduces Lycofertilic™ – high potency, targeted supplements with algae DHA Omega-3 to provide anti-ageing support for the ovarian reserve and to prepare for egg retrieval and IVF

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LONDON, Oct. 23, 2020 — Cambridge Diagnostic Imaging (CaDi) is launching a new generation of targeted daily supplements, LycofertilicTM for fertility support and LycofertilicTM Prime to prepare for egg retrieval and IVF.

The ovarian reserve and egg quality of women declines with age. This depletion is exacerbated by stress, imbalanced diet and obesity and is further deteriorated by inflammatory pathologies of the pelvic organs. These processes, even on a subclinical asymptomatic level, are amogst the main factors negatively affecting natural or artificial fertilisation processes and pregnancy.

Lycofertilic™ has been developed by Lycotec, a company in Cambridge, UK. It is a patented complex of DHA Omega-3, Lutein and Zeaxanthin, which, due to patented technology, helps to provide anti-ageing support for the ovarian reserve in women throughout their fertility years.

It is very important to improve the quality of the egg in its preparation for retrieval and IVF. Lycofertilic™ Prime is an increased dose of this complex developed especially to boost this process.

Clinical trials (link below) demonstrated 250 mg of Lycofertilic™ DHA Omega 3 to be 10-16 times stronger than conventional Omega 3 supplement products and 4–5 times more powerful than Omega 3 pharmaceuticals. This superiority translates into a much more efficient reduction in markers of inflammatory damage and to a boost in peripheral tissue oxygenation and respiration. The increased bioavailability and targeted delivery reduces side effects and makes for unnecessary overconsumption of traditional Omega 3 products.

"According to the World Health Organisation 28 million women around the world encounter fertility problems every year. This is a serious problem which we decided to help to address by launching these new innovative technology-based products. As preparation for IVF is a critical period for the fertilisation process, it is of utmost importance that women receive health products with the highest quality ingredients such as algae DHA Omega-3, and of sustainable origin too" said Alexey Shulepov, CEO of CaDi.

A combination of Lycofertilic™ products with a personalised CaDi AI-based algorithm recommendation provides additional superior efficacy over existing Omega 3. Both Lycofertilic™ products are safe, vegan and their active ingredients are GMO-free and approved for humans.

About CaDi and Lycofertilic™:

http://cambridgediagnostics.co.uk – CaDi official website, online store of Lycofertilic™

lycotec.com – medical research company, developer of technologies of Lycofertilic™ 

https://www.ijabmr.org/article.asp?issn=2229-516X;year=2018;volume=8;issue=3;spage=148;epage=154;aulast=Petyaev – Clinical trials

For any questions please contact – pr@cambridgediagnostics.co.uk

PR Newswire

QYNAPSE (France) and TRUE POSITIVE MEDICAL DEVICES (Canada) are partnering to provide the most advanced AI platform for brain diseases

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Strategic partnership in brain imaging and AI

PARIS, MONTREAL, and QUEBEC CITY, Oct. 13, 2020 —

  • Acquisition of TRUE POSITIVE MEDICAL DEVICES by QYNAPSE
  • A strategic collaboration that covers 15 patents, including 9 issued in the U.S. and Canada
  • A unique technology alliance to improve clinical trials performance and personalize brain diseases management

QYNAPSE SAS, a French medical technology company, today announces the acquisition of the Canadian company TRUE POSITIVE MEDICAL DEVICES Inc. (TPMD), a spin-off from the universities of McGill and Laval. The objective of this strategic collaboration is to combine TPMD’s technologies, patents and expertise with Qynapse’s know-how and product line – and thus form the most advanced artificial intelligence (AI) platform in the field of imaging of brain diseases such as Alzheimer’s, Parkinson’s and multiple sclerosis.

The QyScore application
The QyScore application

Over the past fifteen years, the founders of TPMD, Prof. Louis Collins (McGill University, Montreal, Canada) and Prof. Simon Duchesne (Université Laval, Quebec City, Canada) have established one of the most impressive scientific and technological asset bases in brain imaging and AI applied to this field, supported by more than 500 publications and scientific communications. These technologies are already being used in Canada by leading research consortia and private international players in studies specifically related to neurodegeneration, such as Alzheimer’s disease.

QYNAPSE is already marketing its first QyScore® medical device to clinical centers in Europe and the United States. Its platform is also used in clinical trials involving dozens of centers worldwide. The collaboration with TPMD will allow QYNAPSE to extend the applications of its QyScore® software to other brain diseases such as stroke, epilepsy, autism, schizophrenia, and head trauma – and also to develop new software to predict clinical progression for individual patients and optimize enrollment in clinical trials.

QYNAPSE’s acquisition of TPMD covers 15 patents, including 9 issued in the United States and Canada, grouped into nine technological asset families. The founders of TPMD will join QYNAPSE’s scientific board, setting the stage for a long-term collaboration.

According to Prof. Louis Collins: "QYNAPSE is a very promising partner for TPMD and both McGill and Laval universities, which will allow us to accelerate the regulatory approval and marketing of the technologies we have developed in recent years". Prof. Duchesne adds, "Indeed, with QYNAPSE we will have access to a partner that is already well established in the medical field. We look forward to providing clinicians with the tools they need to improve the accuracy of their diagnosis, facilitate prognosis and guide treatment for diseases such as dementias and cerebrovascular diseases."

"We are delighted to partner with two of the world’s leading experts in brain imaging, and to expand our scientific and clinical collaborations with two major centers of excellence in this field." said Olivier Courrèges, CEO of QYNAPSE. "This collaboration will create a unique technological structure, strengthening our ability to deploy powerful tools to address two major challenges: clinical trial performance and personalized management of brain diseases, which affect more than one in six people worldwide."

Once finalized, TPMD will be integrated into QYNAPSE CANADA Inc. and TPMD’s scientific and commercial partnership contracts will be operated by this new entity.

About QYNAPSE

Founded in 2015, QYNAPSE is a French medical technology company, a spin-off from the CATI consortium of neuroimaging research laboratories. The company develops and markets solutions utilizing the potential of quantitative imaging and artificial intelligence to optimize diagnosis, prognosis and monitoring of patients with neurological diseases.
QYNAPSE is headquartered in Paris (France) and in Boston (USA).
www.qynapse.com 
www.qynapse.com/qyscore-software/ 

About TRUE POSITIVE MEDICAL DEVICES (TPMD)

Founded in 2011, TRUE POSITIVE MEDICAL DEVICE Inc. is a spin-off from the work of Prof. Simon Duchesne at the CERVO Brain Research Center and Université Laval and Prof. Louis Collins at the Montreal Neurological Institute and McGill University. The company designs, validates and operates a brain image processing platform to aid in the diagnosis and prognosis of neurological and psychiatric diseases.
TPMD is based in Montreal and Quebec City (QC, Canada).
www.truepositivemd.com  

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Media Contact
Ysé Sallé de Chou
Qynapse
ysalledechou@qynapse.com

PR Newswire

First Rapid Corona Antigen Test Approved for Clinical Study in Germany

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The health tech company Digital Diagnostics AG from Mainz, Germany, has received approval for clinical trials from a German ethics committee and the Federal Institute for Drugs and Medical Devices (BfArM). This is a crucial regulatory step in the ongoing approval process for the Digid Cantisense™ SARS-CoV-2 test in Germany. The aim of the clinical trials is to demonstrate the reliability of the new technology in comparison with conventional PCR tests. The new test is particularly suitable for access control at airports or at large-scale event

MAINZ, Germany, Aug. 26, 2020 — In June 2020, the health technology company Digital Diagnostics AG from Mainz, applied for approval of the Digid Cantisense™ SARS-CoV-2 test for Germany at the German Federal Institute for Drugs and Medical Devices (BfArM). BfArM has now permitted the conduct of clinical trials in accordance with Section 20 (1) of the German Medical Devices Act (MPG). Meanwhile, the ethics committee of the Rheinland-Pfalz Medical Association (Landesärztekammer) has also given a positive vote.

Completion of the clinical evaluation of the Digid biosensor and the accompanying reading device is expected in October 2020. If the results meet expectations, the rapid Cantisense™ test shall be approved in short succession. Digital Diagnostics AG will then be able to launch the tests on the market in millions. The company currently develops the necessary production capacities, ready for use in time right after the approval.

The leading center to carry out the clinical trials is PFÜTZNER Science & Health Institute in Mainz, which works closely with scientists and MDs from corona test centers and clinics throughout Germany. It is planned to perform the study locally as well as in known German corona hotspots.

In the study, patients are tested in parallel with a standard PCR method and with the Digid Cantisense™ SARS-CoV-2 test. Like with all common SARS-CoV-2 determinations, medical staff takes a throat swab from the patient. The sample is analyzed directly on site with the Digid rapid test system and afterwards compared with the result of a PCR test from a reference laboratory to demonstrate the accuracy of the Digid Cantisense™ SARS-CoV-2 test. The design of the study complies with FDA and EU Commission guidelines for in-vitro measurement procedures to detect SARS-CoV-2.

One key advantage of the Digid Cantisense™ SARS-CoV-2 test is that it directly detects the presence of the virus in the sample, while other available rapid tests mostly detect antibodies. Patients only develop these antibodies if they have had an infection for several days, a time during which they were contagious and might unknowingly have infected others. With the unique combination of immediate on-site detection of the virus in tested patients, the Digid Cantisense™ SARS-CoV-2 test is particularly useful to contain the spread of the pandemic and suitable for on-site access control and rapid testing, for example at airports, in hospitals or at large-scale events.

Press contact

Thomas Huber
semanticom GmbH
+49 30 275 80 81 11
digid-pr@semanticom.eu

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